Equipment Validation Engineer

4 days ago

Dublin, Dublin City, Ireland NNIT Group Full time

Role Brief:
The successful candidate will focus on the validation activities for a range of equipment solutions within a regulated Pharma environment. You will both have responsibility for a number of activities and pieces of equipment while also supporting the wider Validation function and ensuring Validation activities are closed out in line with the Validation Master Plans. At its core, the role will involve drafting documentation (IQ, OQ etc), involvement in validation activities in relation to the execution phase on new equipment and process improvements on current equipment.

Skills Brief:

  • Managing & coordinating the preparation, review & approval of Validation Master Plans
  • Generate, execute and review validation protocols and associated reports for related equipment and processes.
  • Managing & coordinating all validation strategies & deliverables
  • Managing & coordinating the preparation, review & issuing of validation protocols & reports
  • Managing & coordinating validation documentation (risk assessments, traceability matrices)
  • Managing & coordinating the review & approval of specifications associated with Equipment & Processes.
  • Managing & coordinating routine Internal Quality Audits of the facility to ensure compliance & be proactive in resolving issues that may arise.
  • Provide technical direction & hands-on assistance for testing projects

Person Brief:
Candidates must have a Bachelor's degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline with over 3 years of Validation Engineering experience. You must have at least 2 years of experience in Validation activities for equipment found in Pharmaceutical or other GMP regulated environments (Biotech, Biopharma, Life Sciences or Medical Devices). The ideal candidate will have excellent collaboration and communication skills, strong attention to detail and an excellent understanding of validation concepts and documentation. He/she should also have proven ability to solve complex technical & equipment qualification challenges using a rational scientific approach. The candidate should be based in Kilkenny or within a reasonable commute or be willing to relocate to the area as the role will be fully onsite. Only candidates currently meeting this criteria or available and able to relocate in a short timeframe can be considered.

Opportunity Brief:
This is an excellent opportunity to work with clients who are global leaders in their field, helping to develop and improve upon industry-leading technology solutions. NNIT Ireland offers a supportive environment committed to employee development and wellness, along with a competitive and rounded compensation package, which rewards high performers.

Company Brief:
NNIT Ireland are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers, including many of the world's top multinational companies in the medical device and pharmaceutical sectors, achieve their Six Sigma and OEE targets. For over 20 years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway, Limerick, Leinster and Florida USA. We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users, OEM's and Technology providers.

About NNIT

NNIT is a public listed company who specializes in IT solutions to life sciences internationally, and to the public and enterprise sectors in Denmark. We focus on high complexity industries and thrive in environments where regulatory demands and complexity are high. We advise on and build sustainable digital solutions that work for the patients, citizens, employees, end users or customers. NNIT consists of group company NNIT A/S and subsidiaries SCALES, Excellis Health Solutions and SL Controls. Together, these companies employ more than 1,800 people in Europe, Asia, and USA.

We celebrate diversity and are committed to creating an inclusive environment for all employees. All candidates are encouraged to apply for the given job regardless of their gender, age, religious beliefs, sexual orientation, national and social origin, political opinion, disability, race, skin colour, and ethnic origin.

In the interest of fostering a fair and unbiased recruitment process, we kindly request candidates to refrain from including their pictures in their applications.

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